Allogene, genetisch modifizierte T-Zellen (1) – Zalmoxis®

• Clinical trials
  • The TK007 study is a single-arm, uncontrolled clinical study of Phase 1/2 investigating the efficacy and safety of ‘allogeneic, genetically modified T-cells’ as an adjunctive treatment option in haploidentical haematopoietic stem cell transplantation (HSCT).
  • The TK008 study is an ongoing, randomised, controlled Phase 3 trial enrolling adult patients with acute leukaemia.

Allogeneic, genetically modified T-cells as adjuvant therapy in haploidentical haematopoietic stem cell transplantation (HSCT) in adults with high-risk haematological malignancies

• The G-BA assesses the extent of the additional benefit to be assumed, from a purely legal perspective, pursuant to Section 35a(1), sentence 11, first clause, of SGB V, of ‘allogeneic, genetically modified T-cells’ – to be assumed solely from a legal perspective under Section 35a(1), sentence 11, first half-clause, of SGB V – as non-quantifiable, based on the criteria set out in Section 5(7) of the AM-NutzenV, taking into account the severity of the disease and the therapeutic objective in treating the disease.
• An additional benefit exists in accordance with Section 35a(1), sentence 11, first clause, of SGB V, but is non-quantifiable because the scientific evidence currently does not permit this.
• Conclusion
  • To assess the additional benefit, the pivotal study TK007 – a single-arm, uncontrolled clinical study of Phase 1/2 – was submitted, along with data on individual patients from the ongoing Phase 3 study TK008 and a historical control using data from a registry.
  • Overall, based on the study data presented and the historical control, it is not possible to make a valid assessment of the additional benefit of ‘allogeneic, genetically modified T-cells’ in the indicated therapeutic indication.

Courtesy translation only, please refer to the German original.